MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711253E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported a patient with a jejunostomy tube passed through nursing infirmary on (b)(6) 2024.On the night of (b)(6) 2024, when trying to irrigate the tube for the passage of nutrition and medications, it is observed that medication or nutrition is not administered forcefully at the time of administration.In addition to nutritional content by mouth, the head of the service informs the patient's doctor on duty with administration of resincalcium 15g every 8h.The tube is removed due to obstruction and only 50cm of the tube is removed.An x-ray is taken, and a tip is observed in the gastric contents.An endoscopy is performed for the removal of the foreign body (remains of the nasojejunal tube) and passage of a new nasojejunal tube.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2333105464 was reviewed and no anomalies related to the reported issue were observed.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.There were no samples returned for evaluation, therefore the affected device could not be evaluated to confirm the reported failure mode.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20695163
• Report Number: 1423537-2024-00309
• Device Sequence Number: 6556081
• Product Code: KNT
• UDI-Device Identifier: 10884521582927
• UDI-Public: (01)10884521582927(17)281031(10)2333105464
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K112511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884711253E
• Device Catalogue Number: 8884711253E
• Device Lot Number: 2333105464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male